Dysphagia, Dysphagia After Stroke, Stroke, Swallowing Disorders
Conditions
Keywords
Post-Stroke Dysphagia, Swallowing Rehabilitation, Oropharyngeal Exercises, Neuromuscular Electrical Stimulation (NMES), Visual Biofeedback, Surface Electromyography (sEMG), Shear Wave Elastography
Brief summary
Post-stroke dysphagia is a common complication that negatively affects nutritional status, quality of life, and morbidity. Conventional swallowing rehabilitation, including oropharyngeal exercises and neuromuscular electrical stimulation (NMES), is widely used to improve swallowing function. This randomized controlled clinical study aims to investigate the effectiveness of visual biofeedback-assisted oropharyngeal exercises combined with NMES in patients with post-stroke dysphagia. Participants will be randomly assigned to either a visual biofeedback-assisted exercise group or a conventional exercise group, with both groups receiving NMES. Treatment will be administered five days per week for four weeks. Changes in swallowing function, suprahyoid muscle activity assessed by surface electromyography, and muscle stiffness evaluated by shear wave elastography will be analyzed to determine the effectiveness of the intervention.
Detailed description
Post-stroke dysphagia is a frequent complication following cerebrovascular events and is associated with increased risk of aspiration pneumonia, malnutrition, prolonged hospitalization, and reduced quality of life. Rehabilitation strategies aiming to improve swallowing function commonly include oropharyngeal exercises and neuromuscular electrical stimulation (NMES). These approaches are intended to enhance suprahyoid muscle activation, improve hyolaryngeal elevation, and facilitate safer swallowing.Visual biofeedback has recently emerged as a potential method to enhance motor learning and patient engagement during rehabilitation. Providing real-time feedback about muscle activity may improve exercise performance, increase patient motivation, and potentially enhance therapeutic outcomes. However, the clinical effectiveness of visual biofeedback-assisted swallowing exercises in patients with post-stroke dysphagia has not been sufficiently investigated.The aim of this randomized controlled clinical trial is to evaluate the effectiveness of visual biofeedback-assisted oropharyngeal exercises combined with neuromuscular electrical stimulation in patients with post-stroke dysphagia. Adult patients diagnosed with post-stroke dysphagia will be recruited and randomly assigned to one of two groups. The visual biofeedback group will perform conventional oropharyngeal swallowing exercises with visual feedback provided through the NMES device interface, while the control group will perform conventional oropharyngeal exercises without visual feedback. Both groups will receive suprahyoid NMES as part of the rehabilitation protocol.The intervention will be administered five days per week for four weeks. The primary outcome of the study is the change in suprahyoid muscle stiffness measured by shear wave elastography. Secondary outcomes include changes in muscle activation assessed by surface electromyography and improvements in swallowing function and swallowing-related quality of life measured using validated clinical scales.This study is designed as a single-center, randomized, controlled, double-blind academic clinical study conducted at the Department of Physical Medicine and Rehabilitation, Gazi University Faculty of Medicine. The findings of this study may provide evidence regarding the potential benefits of visual biofeedback-assisted swallowing rehabilitation in patients with post-stroke dysphagia.
Interventions
DEVICESuprahyoid Neuromuscular Electrical Stimulation (NMES)
Suprahyoid neuromuscular electrical stimulation will be applied using a clinically approved NMES device as part of the swallowing rehabilitation protocol. Stimulation parameters and electrode placement will follow standard therapeutic guidelines. NMES will be administered five days per week for four weeks.
BEHAVIORALVisual Biofeedback Training
Visual biofeedback will be provided through the NMES device interface using an interactive visual feedback task designed to activate swallowing-related muscles. During the intervention, participants will perform muscle activation tasks guided by real-time visual feedback. The task is designed to engage muscle groups similar to those targeted during conventional oropharyngeal swallowing exercises. The visual biofeedback training will be performed for approximately 20 minutes per session, five days per week for four weeks.
BEHAVIORALConventional Oropharyngeal Exercises
Participants will perform conventional oropharyngeal swallowing exercises targeting swallowing-related muscle groups. The exercise program will consist of four exercises per session, including tongue resistance exercise, Shaker exercise, Mendelsohn maneuver, and effortful swallow. Each exercise will be performed for approximately five minutes per session, five days per week for four weeks. The exercises were selected to activate muscle groups similar to those engaged during the visual biofeedback training.
Sponsors
Gazi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessments will be performed by an assessor who is blinded to group allocation. Participants and therapists providing the intervention will not be blinded due to the nature of the exercise-based intervention.
Intervention model description
Participants with post-stroke dysphagia will be randomly assigned to two parallel groups. The intervention group will receive visual biofeedback-assisted oropharyngeal exercises combined with neuromuscular electrical stimulation (NMES), while the control group will receive conventional oropharyngeal exercises combined with NMES. Both interventions will be administered five days per week for four weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older * Clinical diagnosis of dysphagia, defined by at least one of the following: presence of cough or throat clearing during the 90 mL water swallow test, reduced laryngeal elevation on clinical examination, or at least one symptom related to dysphagia * Ability to initiate reflex swallowing * History of cerebrovascular event within the previous 6 months * Stable vital signs * Ability and willingness to provide written informed consent
Exclusion criteria
* Severe cognitive impairment (Mini-Mental State Examination \[MMSE\] score \< 20), dementia, or severe communication difficulties due to aphasia * Contraindications to electrical stimulation, including the presence of an * implantable cardioverter-defibrillator (ICD), impaired skin integrity or open wounds at the electrode placement site, or active epilepsy * History of cervical surgery or presence of respiratory distress * Diagnosis of malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Suprahyoid Muscle Stiffness Measured by Shear Wave Elastography | Baseline and 4 weeks (end of treatment | Change in stiffness of the suprahyoid muscles (geniohyoid and anterior digastric) measured using shear wave elastography (SWE). Muscle stiffness will be quantified in kilopascals (kPa), and the difference between baseline and post-treatment measurements will be compared between groups. |
| Change in Geniohyoid Muscle Thickness | Baseline and 4 weeks (end of treatment) | Change in geniohyoid muscle thickness measured using ultrasound imaging during shear wave elastography assessment. The difference between baseline and post-treatment measurements will be evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Suprahyoid Muscle Peak Amplitude (sEMG) | Baseline, 2 weeks (interim assessment), and 4 weeks (end of treatment | Change in peak amplitude of suprahyoid muscle activity measured using surface electromyography during effortful swallowing. Measurements will be obtained during three repetitions of effortful swallowing with 5 cc water, with rest periods between repetitions. |
| Change in Swallowing Function Measured by Gugging Swallowing Screen (GUSS) | Baseline and 4 weeks | Swallowing function will be assessed using the Gugging Swallowing Screen (GUSS). Total scores range from 0 to 20, with higher scores indicating better swallowing function and lower aspiration risk. Changes in total scores will be evaluated over time. |
| Change in Functional Oral Intake Scale (FOIS) | Baseline and 4 weeks | Functional oral intake will be assessed using the Functional Oral Intake Scale (FOIS). Scores range from 1 to 7, with higher scores indicating better oral intake and functional feeding ability. |
| Change in Eating Assessment Tool (EAT-10) | Baseline and 4 weeks | Patient-reported swallowing difficulty will be evaluated using the Eating Assessment Tool-10 (EAT-10). Total scores range from 0 to 40, with higher scores indicating greater dysphagia severity. |
| Change in Swallowing-Related Quality of Life (SWAL-QOL) | Baseline and 4 weeks | Swallowing-related quality of life will be assessed using the Swallowing Quality of Life Questionnaire (SWAL-QOL). Scores range from 0 to 100, with higher scores indicating better swallowing-related quality of life. |
| Change in Suprahyoid Muscle RMS Activity (sEMG) | Baseline, 2 weeks, 4 weeks | Change in average root mean square (RMS) of suprahyoid muscle activity measured using surface electromyography during effortful swallowing under standardized conditions. |
| Change in Suprahyoid Muscle Activity (%MVC) | Baseline, 2 weeks, 4 weeks | Change in normalized suprahyoid muscle activity expressed as percentage of maximum voluntary contraction (%MVC) measured using surface electromyography. |
Countries
Turkey (Türkiye)
Contacts
CONTACTIlgın N Manzak, MD
Outcome results
None listed